Daewoong Pharmaceuticals Collaborates with St. Mary’s Hospital to Seek Approval for Off-Label Use of Foistar Targeting COVID-19 Patient Cases

Daewoong Pharmaceuticals Collaborates with St. Mary’s Hospital to Seek Approval for Off-Label Use of Foistar Targeting COVID-19 Patient Cases

Could an existing drug for pancreatitis be used to target COVID-19?  Apparently, that’s a claim now unfolding in Korea as Daewoong Pharmaceuticals applied to market the drug known as Foistar (camostat mesylate) off-label in that nation. In Korea, off-label use targeting COVID-19 requires approval from the Health Insurance Review and Assessment Services (HIRA) and buy-in from an ethics committee and health regulators. Apparently, the company has already completed a Phase 2a clinical trial investigating the use of Foistar for mild COVID-19 patients at the end of last year. The results failed to achieve statistical significance but they were apparently associated with viral clearance. Korean Ministry of Food and Drug Safety thereafter approved a 300 patient Phase 2/3 clinical trial to start this month. In a search in clinicaltrials.gov, TrialSite found a Daewoong Pharmaceuticals’ Phase 3 clinical trial combining Foistar and Remdesivir involving 1,120 patients to start this month. Daewoong Pharmaceuticals declared it could possibly have interim results by mid-March 2021. In the meantime, the company elicited the support of St. Mary’s Hospital for an evaluation of the drug within 15 da...

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